Turbett Surgical Container, TS1500
FDA device recall Z-1501-2022 · posted 2022-08-04 · Terminated
Recall details
- Recalling firm
- Turbett Surgical, Inc.
- Reason for recall
- Devices were subject to unapproved rework processes.
- Action taken
- The firm distributed recall notification to hospitals via email on 04/14/2022. The recall notification identifies the reason for recall of specific TS1500 units to be that the repair process employed could restrict the customer's ability to clean and visually check the device for cleanliness. This can be identified by the customer by evidence of bioburden or particulate buildup in the seams of the device. Inadequate or incomplete cleaning of the unit may compromise the sterility of the load. The firm asks customers to immediately discontinue use of the device and complete the provided Return Response Form to Quality@Turbettsurgical.com. Turbett will contact customers to coordinate the replacement of the unit and correction of the recalled device. Customers with any questions can call 585-755-0133x106 from Monday through Friday, from 8:00 AM to 4:30 PM.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRG
- Quantity affected
- 7 units
- Distribution
- US Nationwide Nationwide: CO, FL, NC and PA.
- Date initiated
- 2022-04-14
- Date posted
- 2022-08-04
- Date terminated
- 2025-02-20
- Location
- Victor, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Turbett Surgical Container (K153025) | Turbett Surgical, LLC | 2016-01-14 |